BS EN 16844:2017+A2:2019
$198.66
Aesthetic medicine services. Non-surgical medical treatments
Published By | Publication Date | Number of Pages |
BSI | 2019 | 56 |
This European Standard addresses the requirements for certain aesthetic non-surgical medical treatments:
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treatments with resorbable injectables, botulinum toxin and micro needling;
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treatments with non-ablative fractional resurfacing and superficial peels, lasers and comparable energy based devices;
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treatments with fractional ablative lasers and comparable energy based devices and medium depth peels; and
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other treatments such as deep chemical peels, full ablative lasers and thread lifts.
This European Standard provides recommendations for aesthetic non-surgical medical treatments, including the ethical framework and general principles according to which aesthetic medicine services are provided by all practitioners and stakeholders of the aesthetic medical field. These recommendations apply before, during and after the treatment.
Any aesthetic medical treatment that goes deeper than the stratum corneum or which has, or claims to have, a biological effect beyond the stratum corneum (with or without instrument or devices) is included in the scope of this European Standard.
Aesthetic surgical procedures covered by EN 16372 and dentistry1) procedures are excluded from the scope of this European Standard.
Aesthetic non-medical treatments (tattooing and any treatment not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard.
PDF Catalog
PDF Pages | PDF Title |
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2 | National foreword |
8 | 1 Scope 2 Terms and definitions |
10 | 3 Competencies 3.1 General |
11 | 3.2 Training 3.3 Continuous professional development (CPD) and continuous medical education (CME) 4 Management and communication with patients 4.1 Office staff/Booking arrangements |
12 | 4.2 Patient consultation and assessment |
13 | 4.3 Consent |
14 | 4.4 Documentation |
15 | 4.5 Post-treatment follow up and patient satisfaction 4.6 Advertising |
16 | 4.7 Medical tourism and travelling long distance for treatment |
17 | 4.8 Medical indemnity and insurance 4.9 Fees 4.10 Arrangements for out of hours and emergency cover |
18 | 4.11 Complaints 4.12 Confidentiality 4.13 Safe timing of treatments 4.14 Registration 5 Facilities 5.1 Evaluation of compliance and risk management 5.2 Personnel |
19 | 5.3 Documentation of medical records 5.4 Facility 5.5 Administrative and waiting area 5.6 General requirements and recommendations for treatment rooms and procedure rooms |
20 | 5.7 Patient safety and security |
21 | 5.8 Hygiene standards for treatment rooms and procedure rooms |
22 | 5.9 Medicines Management |
23 | 5.10 Treatment room (TR) 5.11 Procedure room (PR) |
25 | 6 Treatments 6.1 General 6.2 Aesthetic medical treatment categories 6.3 Identifying factors 6.3.1 General |
26 | 6.3.2 Practitioner 6.3.3 Facility 6.3.4 Anaesthesia level 6.3.5 Risk level of treatment |
27 | 6.3.6 Patient physical status and age |
28 | 6.3.7 Mental status and patient expectations 6.4 Treatment identification 6.5 Cooling off period 6.6 Aesthetic medical treatments |
31 | Annex A (normative)Code of Ethics for marketing and advertising |
33 | Annex B (informative)A–deviations |